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Recruiting NCT06467474

Psychoeducational Group for Depression

No phase Interventional Major Depressive Disorder (MDD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEG-D program, TAU.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD. Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Psychoeducation for Major Depressive Disorder: Development and Evaluation of Effectiveness

Overview

The study aims to investigate the efficacy of a psychoeducational program as an adjunctive treatment for depression. The study will involve 338 patients diagnosed with Major Depressive Disorder (MDD) of moderate severity. Participants will be randomly assigned to receive either Treatment as usual (TAU) alone or TAU plus the psychoeducational program. The program consists of six weekly group sessions covering information and techniques for coping with depression. Primary outcomes include a reduction in depressive symptoms measured by the Beck Depression Inventory-II (BDI-II) and increased knowledge of depression. Secondary outcomes include improvements in functionality and quality of life. The study aims to provide insights into the effectiveness of psychoeducation in improving outcomes for individuals with depression

Interventions

  • Behavioral PEG-D program
    PEG-D will be carried out in person, open format, for six consecutive weeks lasting 90 minutes each. An approximate group of 6 to 10 participants will be led by a team of experienced psychologists and psychiatrists. Each group will have a main therapist and a co-therapist to ensure effective support and guidance for participants. Before the start of the group, participants received a booklet containing the content of the sessions.
  • Drug TAU
    The treatment will start with Sertraline (SSRI) - doses of 50 mg and adjusting as necessary according to the patient\'s profile. After 8 weeks, if the patient experiences remission, they will continue on monotherapy with Sertraline. In case of relapse Bupropion, Quetiapine, Lithium or Aripiprazole might be add-on. In this case, add-on medications will be determined according to the patient profile, by the clinician. If there is a response above 25% of the symptoms, but without remission, the

Primary outcome measures

  • Knowledge level [Time frame: Time: baseline, post 6 weeks and 12 months.]
  • Depressive levels [Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.]
Secondary outcome measures (3)
  • Depressive Thoughts [Time frame: Baseline, post 6 weeks, 3, 6 and 12 months]
  • Avoidance behaviors [Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.]
  • Functionality [Time frame: Baseline, post 6 weeks, 3, 6 and 12 months.]

Eligibility criteria

Inclusion:

  • Both sexes;
  • Ages between 18 and 65 years old;
  • Diagnosis of Major Depressive Disorder (MDD) made by a clinician according to Diagnostic Statistical Manual criteria-5-Text Revised (DSM-5-TR)
  • Patients with Hamilton Depressive Rating Scale-17 items (HDRS-17) scores 14-23;
  • Informed and signed consent form.

Exclusion:

  • Unstable serious clinical or neurological diseases;
  • Postpartum depression or other types of depressive disorders (disruptive mood dysregulation disorder, pre-menstrual, substance/medication-induced depressive disorder, depressive disorder due to another medical condition, another disorder specified depressive disorder and unspecified depressive disorder);
  • Other psychiatric disorders;
  • Patients with active psychotic symptoms;
  • Suicidality risks
  • Patients already undergoing any other psychological treatment for MDD;

Discontinuation:

  • More than two absences during treatment;
  • Those who miss more than two sessions/consultations, whether medical treatment or the psychoeducational program;
  • Non-response to the use of Sertraline over the initial eight weeks; Presence of hypomanic symptoms at any time during treatment (Young \<7)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Institute of Psychiatry - Faculty of Medicine from University of Sao Paulo — São Paulo

Publications

  • Carneiro AM, Silva SLT, Fernandes FDS, Barretto JR, de Brito TR, Moreno LH, Pimentel FC, Jorge BA, Dos Santos LA, Fernandes Ramos MR, Moreno RA. Psychoeducation Group for Depression (PEG-D): Study protocol for a prospective, randomized, single-blind, crossover trial. PLoS One. 2025 Aug 8;20(8):e0329006. doi: 10.1371/journal.pone.0329006. eCollection 2025. PMID 40779501

Identifiers

NCT: NCT06467474 · 76212623.1.0000.0068

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗